Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea

Conditions

Irritable Bowel Syndrome with diarrhoea (IBS-D) Digestive System Irritable bowel syndrome with diarrhoea

Carol A. Howell, Anu Kemppinen, Victoria Allgar, Matthew Dodd, Charles H. Knowles et al. (10 authors)

Gut2022-06-2730 citations

10.1136/gutjnl-2022-327293

Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults

Anu Kemppinen, Carol A. Howell, Victoria Allgar, Matthew Dodd, John Gregson et al. (11 authors)

Trials2020-01-3014 citations

10.1186/s13063-020-4069-x

Interventions

Using a centralised computer-based randomisation tool, patients will be randomised 1:1 to receive intestinal adsorbent Enterosgel® or placebo. The patients will receive blinded study treatment for 8 w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 04/04/2019: 1. Written informed consent 2. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria 3. Aged 16-75 4. Considered suitable to take part in the study by the consenting doctor/nurse 5. Diary completed on at least 11 of 14 days (=75%) during the screening period Previous inclusion criteria from 17/10/2018 to 04/04/2019: 1. Written informed consent 2. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria 3. Aged 18-75 4. Considered suitable to take part in the study by the consenting doctor/nurse 5. Diary completed on at least 11 of 14 days (=75%) during the screening period Original inclusion criteria: 1. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria 2. Negative calprotectin test or adequate exclusion of Inflammatory Bowel Disease (IBD) 3. Aged 18+ 4. Considered suitable to take part in the study by the consenting physician

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 07/01/2020: 1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit 2. Average abdominal pain <2.5 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain) 3. Previously diagnosed coeliac disease 4. Previously diagnosed Inflammatory Bowel Disease 5. Previous bowel cancer or bowel resection 6. Other previously known gastrointestinal disorder contributing to the diarrhoea 7. Unexplained weight loss 8. Unexplained rectal bleeding 9. Previous use of Enterosgel® 10. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks 11. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids 12. Participation in any research where treatment is provided, or was provided in the last three months 13. Pregnancy Previous exclusion criteria from 04/04/2019 to 07/01/2020: 1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit 2. Average abdominal pain <3 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain) 3. Previously diagnosed coeliac disease 4. Previously diagnosed Inflammatory Bowel Disease 5. Previous bowel cancer or bowel resection 6. Other previously known gastrointestinal disorder contributing to the diarrhoea 7. Unexplained weight loss 8. Unexplained rectal bleeding 9. Previous use of Enterosgel® 10. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks 11. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids 12. Participation in any research where treatment is provided, or was provided in the last three months 13. Pregnancy Previous exclusion criteria from 17/10/2018 to 04/04/2019: 1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit 2. Average abdominal pain <3 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain) 3. IBS-SSS=400 4. Previously diagnosed coeliac disease 5. Previously diagnosed Inflammatory Bowel Disease 6. Previous bowel cancer or bowel resection 7. Other previously known gastrointestinal disorder contributing to the diarrhoea 8. Unexplained weight loss 9. Unexplained rectal bleeding 10. Previous use of Enterosgel® 11. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks 12. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids 13. Participation in any research where treatment is provided, or was provided in the last three months 14. Pregnancy Original exclusion criteria: 1. Loose stools (BSFS 6 or 7) on less than 3 days during the last 14 days

Design outcomes

Primary

Measure	Time frame
Percentage of patients defined as responders for abdominal pain and stool consistency based on daily study diary data, during at least 4 weeks in the 8-week blinded treatment period, where: 1. An Abdominal Pain Intensity Weekly Responder is defined as a patient who experiences a decrease in the weekly average abdominal pain score of at least 30 percent compared with baseline. The weekly average abdominal pain score is derived by scoring the worst pain experienced each day and taking the average for one week AND 2. A Stool Consistency Weekly Responder is defined as a patient who experiences a 50 percent or greater reduction in the number of days per week with at least one stool that has a consistency of Bristol Stool Form Scale (BSFS) Type 6 or 7 compared with baseline	—

Measure

Time frame

Percentage of patients defined as responders for abdominal pain and stool consistency based on daily study diary data, during at least 4 weeks in the 8-week blinded treatment period, where: 1. An Abdominal Pain Intensity Weekly Responder is defined as a patient who experiences a decrease in the weekly average abdominal pain score of at least 30 percent compared with baseline. The weekly average abdominal pain score is derived by scoring the worst pain experienced each day and taking the average for one week AND 2. A Stool Consistency Weekly Responder is defined as a patient who experiences a 50 percent or greater reduction in the number of days per week with at least one stool that has a consistency of Bristol Stool Form Scale (BSFS) Type 6 or 7 compared with baseline

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Secondary

Measure	Time frame
Original secondary outcome measures: Double-blind treatment phase and open-label treatment phase: 1. Stool frequency based on daily study diary data; mean over 8 weeks and the last 4 weeks of each treatment period 2. Stool consistency assessed as average number of days/week with Bristol Stool Scale type >5 based on daily study diary data and percentage of responders over 8 weeks and the last 4 weeks of each treatment period 3. Abdominal pain based on daily study diary data; mean on a VAS scale from 0 to 10 over 8 weeks and the last 4 weeks, percentage of responders over 8 weeks and the last 4 weeks of each treatment period 4. Bloating based on weekly study diary data; mean weekly score on a numerical scale from 0 to 6 over 8 weeks and the last 4 weeks of each treatment period 5. Urgency based on weekly study diary data; mean weekly score on a numerical scale from 0 to 6 over 8 weeks and the last 4 weeks of each treatment period 6. Percentage of patients reporting adequate relief of global IBS symptoms based on weekly study diary data weekly from baseline until week 8 of each treatment period 7. Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score weekly from baseline until week 8 of each treatment period 8. Irritable Bowel Syndrome Quality of Life (IBS-QOL) score every 4 weeks from baseline until week 8 of each treatment period 9. Patient Health Questionnaire-12 Somatic Symptom scale (PHQ-12 SS) score to measure severity of somatic symptoms excluding gastrointestinal symptoms every 4 weeks from baseline until week 8 of each treatment period 10. IBS-related Work Productivity and Activity Impairment (WPAI:IBS) score; weekly from baseline until week 8 of each treatment period 11. Use of rescue medication, i.e. loperamide, based on weekly study diary data; number of	—

Measure

Time frame

Original secondary outcome measures: Double-blind treatment phase and open-label treatment phase: 1. Stool frequency based on daily study diary data; mean over 8 weeks and the last 4 weeks of each treatment period 2. Stool consistency assessed as average number of days/week with Bristol Stool Scale type >5 based on daily study diary data and percentage of responders over 8 weeks and the last 4 weeks of each treatment period 3. Abdominal pain based on daily study diary data; mean on a VAS scale from 0 to 10 over 8 weeks and the last 4 weeks, percentage of responders over 8 weeks and the last 4 weeks of each treatment period 4. Bloating based on weekly study diary data; mean weekly score on a numerical scale from 0 to 6 over 8 weeks and the last 4 weeks of each treatment period 5. Urgency based on weekly study diary data; mean weekly score on a numerical scale from 0 to 6 over 8 weeks and the last 4 weeks of each treatment period 6. Percentage of patients reporting adequate relief of global IBS symptoms based on weekly study diary data weekly from baseline until week 8 of each treatment period 7. Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score weekly from baseline until week 8 of each treatment period 8. Irritable Bowel Syndrome Quality of Life (IBS-QOL) score every 4 weeks from baseline until week 8 of each treatment period 9. Patient Health Questionnaire-12 Somatic Symptom scale (PHQ-12 SS) score to measure severity of somatic symptoms excluding gastrointestinal symptoms every 4 weeks from baseline until week 8 of each treatment period 10. IBS-related Work Productivity and Activity Impairment (WPAI:IBS) score; weekly from baseline until week 8 of each treatment period 11. Use of rescue medication, i.e. loperamide, based on weekly study diary data; number of

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Countries

England, United Kingdom

Outcome results

None listed